On May 11, 2021 Medigene AG (Medigene, FSE: MDG1, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported an update on the first quarter of 2021 and confirms its financial guidance for the full year (Press release, MediGene, MAY 11, 2021, View Source [SID1234579693]). The full version of the Quarterly Statement Q1 2021 can be downloaded here: View Source
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Prof. Dolores Schendel, Chief Executive Officer and Chief Scientific Officer at Medigene: "Medigene’s development projects continued to progress well in the early part of 2021 as demonstrated by the increased tempo of presentations at international conferences and by the peer-reviewed publication of our work on the MAGE-A4-specific TCR in collaboration with bluebird bio.
While we anticipate reporting results later in 2021 for part 1 of our Phase I/II clinical trial of MDG1011 in blood cancer, we are pushing forward in our developments targeting solid tumors where we have achieved impressive preclinical results on multiple projects including the selection of optimal T cell receptors (TCRs), unique new tumor-specific antigens, and functional enhancements for T cell receptor-modified T cells (TCR-Ts) such as the PD1-41BB switch receptor to conquer the hostile tumor environment, among others.
To further enhance Medigene’s value, we continue to evaluate new partnering opportunities related to our suite of TCR technologies and portfolio of product candidates."
Business review since beginning of 2021 and outlook
In advancing its activities towards solid tumor indications, Medigene continues the research and development work on its suite of technologies and product candidates:
* TCR-4, Medigene’s lead TCR candidate against solid tumors, is a non-mutated TCR isolated using Medigene’s high-throughput screening platform that specifically recognizes a peptide stemming from the PRAME protein presented by human leukocyte antigen (HLA) A2. PRAME is expressed by a variety of solid cancer types. TCR-4 is highly sensitive for this PRAME epitope and its activity has been demonstrated both in vitro (against a variety of tumor cell types including lung cancer, uterine carcinoma, melanoma, and ovarian cancer, among others) and in an in vivo model against melanoma.
* The PD1-41BB switch receptor is the most advanced of the TCR-T enhancements currently being developed by Medigene. A key mechanism in the ability of solid tumors to evade attack by T cells includes the expression of the checkpoint molecule PD-L1 on the surface of tumor cells. Medigene’s PD1-41BB switch receptor turns the tumors’ off-signal sent by PD-L1 into an activation signal for the TCR-T cells. As shown at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper) virtual meetings in March and May 2021, respectively, adding the PD1-41BB switch receptor improved the function of TCR-T cells in a challenging tumor environment over repeated cycles. The PD1-41BB switch receptor also enhanced the metabolic fitness of TCR-T cells and their antigen target-specific killing of tumor cells.
* Under the collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) which were found to be shared among specimens of several patients with solid tumors of different origin, such as ovarian, breast, and lung cancer. As presented at the AACR (Free AACR Whitepaper) virtual meeting, Medigene’s high-throughput screening technology identified ten peptides as immunogenic and able to induce specific T cell responses. The sequences of more than 20 TCRs recognizing these novel TSAs were determined and additional characterization was presented recently at the CIMT (Free CIMT Whitepaper) virtual meeting. With ongoing work these TCRs have the potential to become next-generation TCR-T therapy candidates.
* Medigene continues to enroll and treat patients in the Phase I/II clinical trial of MDG1011 against blood cancers. Dosing of the first three dose cohorts of the Phase I safety and feasibility part of the trial is expected to be completed by the end of Q2 2021. In line with Medigene’s focus on solid cancers the Company has decided that, contingent on the results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.
* Consistent with the company’s decision to focus its development efforts on solid cancers, the MDG1021 development program was discontinued in January 2021. All rights to the HA-1-specific TCR, as well as sponsorship of the Phase I clinical trial, are being transferred to a third party.
* Medigene has developed a new generation of dendritic cell (DC) vaccines. The positive results of the completed open-label Phase I/II clinical trial in patients suffering from acute myeloid leukemia were confirmed even after more than 3.5 years of median follow-up, as reported in February 2021. Consistent with Medigene’s development focus on TCR-T therapies, the DC vaccine project will only be continued with partners.
* Medigene continues its successful collaborations with bluebird bio, Inc. (bluebird bio) and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant). To maximize the Company’s value, it continues to evaluate new partnering opportunities related to its suite of TCR technologies and portfolio of product candidates.
Financial development and financial forecast
* As of 31 March 2021, cash and cash equivalents and fixed-term deposits amounted to Eur26.482 m (31 December 2020: Eur30.033 m). The decrease is primarily due to research and development expenses to advance Medigene’s clinical and preclinical activities.
* Total revenue in the first quarter 2021 increased to Eur2.153 m from Eur1.403 m in the first quarter 2020 due to higher revenues resulting from research and development services from strategic partnerships. Revenue in the first quarter of 2021 also includes revenue from the derecognition of contract liabilities.
* Research and development expenses of Eur4.012 m were Eur2.126 m lower than in the prior-year quarter (Q1 2020: Eur6.138 m) which is mainly due to the increased focus on certain TCR-T therapies for the treatment of solid tumors.
* As a result, earnings before interest, taxes, depreciation and amortization (EBITDA) increased by Eur2.871 m on the prior-year quarter (Q1 2020: Eur-5.949 m), amounting to Eur-3.078 m in the first quarter 2021.
Medigene confirms its financial forecast for 2021 published in the Group Management’s Discussion and Analysis 2020. The Company continues to expect total revenue of Eur7 – 9 m in 2021, research and development expenses of Eur14 – 20 m, and an EBITDA loss of Eur10 – 17 m.
Currently, Medigene expects no material influence of the COVID-19 pandemic on total revenue, research and development expenses and loss at EBITDA level. Based on current planning, the Company has sufficient financial resources to fund operations into the third quarter of 2022.
Conference call
Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2021 but we remain available in the usual way for all enquiries.